Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis

Double Blind, Multicenter, Randomized, Placebo-controlled, Parallel-group, Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis

The purpose of this study is to evaluate the efficacy and safety of the investigational products in the patients with gastritis during their participation in the study.

GC6101A is botanical drug products made from the Lonicerae Flos. Two hundred volunteers will participate in the study, receive 2-week treatment with GC6101A or placebo.

Inclusion Criteria:

• Age is over 19 years old, men or women
• Patients diagnosed with acute or chronic gastritis by gastroscopy
• Patients with one or more erosions found by gastroscopy
• Signed the informed consent forms

Exclusion Criteria:

• Patients who is impossible to receive gastroscopy
• Patients with peptic ulcer and gastroesophageal reflux disease
• Patients with gastroesophageal surgery and surgery to reduce the secretion of gastric acid (Except for surgery for perforated peptic ulcer and cecectomy)
• Patients with esophageal varix
• Patients with malignant neoplasm of gastrointestinal tract
• Patients with thrombosis or administered with anti-thrombotic drugs
• Patients with consumption coagulopathy
• Patients administered with H2 receptor antagonists, muscarinic receptor antagonists, gastrin receptor antagonist, proton pump inhibitors, prostaglandins or mucosal protective agents prior to study in 2 weeks
• Patient who cannot interrupt steroid, non-steroid anti-inflammatory drugs or aspirin during treatment
• Allergic or hypersensitive to any of the ingredients in the test products
• Pregnant or lactating female
• Patients who have abnormal baseline laboratory test result
• Patients taking other investigational drugs within 30 days prior to the study.
• Patients with Zollinger-Ellison syndrome
• Patients that investigators consider ineligible for this study